Description

This is a phase 3 global, multi-center, open-label comparison of ipilimumab with and without intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease progression while on nivolumab or pembrolizumab.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective is to compare the efficacy of IMO-2125 in combination with ipilimumab versus ipilimumab alone.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

Have histologically confirmed metastatic melanoma with measurable (by RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease that is accessible for injection

Have confirmed progression during or after treatment with either nivolumab or pembrolizumab

In addition, all the following must apply:

No intervening anti-cancer therapy between the last course of nivolumab or pembrolizumab and the first dose of the study treatment except for local measures (e.g., surgical excision or biopsy, focal radiation therapy).

The interval between the last nivolumab or pembrolizumab and the start of the study treatment should be at least 21 days with no residual anti-PD-1-related immune toxicities in excess of grade 1 severity.

If BRAF mutation status is unknown, before randomization the subject must have BRAF testing performed using an approved assay method.

Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone of in combination with a MEK inhibitor) or declined targeted therapy.

Patients must have Eastern Cooperative Oncology Group (ECOG) performance status.

Patients must meet protocol-defined laboratory criteria.

Excluding patients who:

Have ocular melanoma

Have had prior therapy with a toll-like receptor (TLR) agonist, excluding topical agents

Have had prior ipilimumab treatment with the exception of adjuvant treatment completed at least six months prior to enrollment

Have had systemic treatment with interferon (IFN) within the previous six months

Have a known hypersensitivity to any oligodeoxynucleotide

Have an active autoimmune disease requiring disease-modifying therapy at the time of screening

Have required systemic steroid therapy should be receiving ≤ 10 mg/day of prednisone (or equivalent) for the two weeks preceding start of study

Have another primary malignancy that has not been in remission for at least three years, with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on a biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic)

Have an active systemic infection(s) requiring antibiotics

Have an active hepatitis A, B or C infection

Have a known diagnosis of human immunodeficiency virus (HIV) infection